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Systemic Targeted Adaptive RadioTherapy of NeuroEndocrine Tumors.
Sponsor: Lund University Hospital
Summary
There are several ways of personalizing PRRT (peptide receptor radionuclide treatment) in NEN (neuroendocrine neoplasia). Nevertheless, the current treatment regimen is not personalized. This trial aims to compare personalized PRRT to non-personalized PRRT in terms of safety, efficacy and resource demands in order to optimize treatment outcomes in an evidence-based manner in future.
Official title: Systemic Targeted Adaptive RadioTherapy of NeuroEndocrine Tumors. An Open-label, Multicenter, Randomized Phase III Trial Comparing Safety and Efficacy of Personalized Versus Non-personalized Radionuclide Therapy With 177Lu (Lutetium)-DOTATOC.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2022-11-01
Completion Date
2026-10-01
Last Updated
2025-09-10
Healthy Volunteers
No
Conditions
Interventions
177Lu-DOTATOC
The investigational medicinal product (IMP) is 177Lu-DOTATOC which is registered as an orphan drug by the EMA ( European Medicines Agency) for the treatment of GEP-NEN (gastro-entero-pancreatic neuroendocrine tumor). The IMP will be administered to participants both in the control arm and the experimental arms, but with different intervals, but the same activity; 7.5 Gbq per dosing.
Capecitabine
Will be given orally with a dose of 825/m2 twice daily, starting on day 1 of each of the 4 first treatment cycles, cycle length 3 weeks.
Locations (4)
Sahlgrenska University Hospital, Dept. of Oncology
Gothenburg, Sweden
Skåne University Hospital, Dept. of Oncology
Lund, Sweden
Karolinska University Hospital, Dept. of Oncology
Stockholm, Sweden
Accademical Hospital, Uppsala, Dept. of Oncology
Uppsala, Sweden